- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03256591
Implementation of HBB Training With Facilitators That Have Undergone Simulation Methodology Training (SimHBB)
A Comparison of the Implementation of HBB Training Using Facilitators With and Without Simulation Methodology Training
Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.
Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries.
High levels of physical, emotional and conceptual realism are important features of simulation-based learning that impact learning outcomes. Formal debriefing is characterized as the most important element of simulation based education. Structured feedback in a safe learning environment provides the opportunity for learning of clinically relevant material. Guided reflection transfers the responsibility for learning to the participants and solidifies knowledge, skills and behaviors for transfer to clinical practice.
Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bushenyi
-
Ishaka, Bushenyi, Uganda, 256
- Recruiting
- Kampala International University
-
Contact:
- Cathy Kyakwera, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Only trained facilitators are eligible to participate
- Must hold a Faculty position or are a health care provider at KIU Teaching Hospital in western Uganda
- Are engaged in teaching health students.
- Participating medical students are those enrolled at KIU Teaching Hospital in western Uganda
Exclusion Criteria:
- Faculty and hospital workers who are not engaged in teaching health students.
- Medical students not enrolled at KIU Teaching Hospital, western Uganda
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HBB plus simulation training
Participants receive training from facilitators for HBB training with simulation skills
|
HBB training from facilitators with simulation skills.
Standard HBB facilitators do not have simulation skills
|
|
No Intervention: Control
Participants receive training from facilitators for HBB training without simulation skills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge
Time Frame: Change in knowledge scores at 6 months from Baseline
|
The primary outcome for this analysis is level of knowledge.
For each course, learners will be assessed at baseline and at course-end to determine their knowledge via multiple choice test.
Scores out of 100% will be computed
|
Change in knowledge scores at 6 months from Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical skills
Time Frame: Change in clinical skills at 6 months from baseline
|
The clinical skills outcome (via short neonatal resuscitation simulation scenario - HBB OSCE B).
HBB OSCE B assessment will be conducted by the facilitator.
|
Change in clinical skills at 6 months from baseline
|
|
Facilitator debriefing skills
Time Frame: Change in facilitator skills at 6 months from baseline
|
Facilitator debriefing skills will be assessed using the OSAD.
OSAD assessments will be conducted by a pre-trained rater who will rate facilitator performance in real time.
|
Change in facilitator skills at 6 months from baseline
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MUST 21/06-16c
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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